Z-2558-2014Class II

CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part...

Name: Z-2558-2014 CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part...
Creator: Civco Medical Instruments Inc
Published: 2014-08-01
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2014-08-01 / Terminated / root cause: packaging

FDA source

Civco Medical Instruments Inc began a recall of CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is... on 2014-08-01. FDA classified it as Class II and gives the reason as "A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2558-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-01
Posted: 2014-08-28
Terminated: 2015-01-28
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery.
Product code: KQT Evacuator, Gastro-Urology
Reason for recall: A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Root cause tag: packaging
FDA root cause: Packaging
Action: Civco Medical Instrucments contacted customers by phone and sent an Urgent Medical Device Recall letter dated August 1, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return all the affected product. Customers were instructed to contact Customer Service at 319-248-6520 with any concerns or questions.
Quantity in commerce: 52 kits
Distribution: Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.
Product codes and lots: Lot numbers: M431760, M431710, M426580, M430200, M423010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2558-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2558-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-28

Product code KQT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)